REG - Ovoca Bio PLC - Completion of Enrollment in Phase II Study

Ovoca BioAnnouncement

29/07/2022 07:01

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220729:nRSc1440Ua&default-theme=true

RNS Number : 1440U  Ovoca Bio PLC  29 July 2022

Ovoca Bio plc

 

("Ovoca" or the "Company")

 

Ovoca Bio Announces Completion of Enrollment in Phase II Dose Ranging Study
Assessing Orenetide for HSDD

 

Dublin, Ireland, 29 July 2022 - Ovoca Bio, a biopharmaceutical company with a
focus on women's health, today announces the successful completion of the
enrollment of participants in a Phase II dose ranging study assessing
Orenetide (the "Study"), a novel treatment for premenopausal women with
hypoactive sexual desire disorder ("HSDD"). HSDD is a condition characterized
by a distressing lack or loss of sexual desire. Despite a challenging global
environment due to COVID-19 restrictions, the company is pleased to have
successfully completed the enrollment in accordance with the previously
announced timeline and schedule.

 

This Phase II dose ranging Study is being conducted in Australia and New
Zealand in order to investigate Orenetide administered daily at a range of
doses, evaluating the effect of the drug on lack or loss of sexual desire
experienced by Study participants. 667 women have been screened in this
double-blind placebo-controlled Study to allow up to 462 participants to be
treated across 13 sites. The Ovoca management team currently expects that all
enrolled participants will complete the Study in the next four months, which
will allow the assessment of study results in Q1 2023.

 

The co-primary objectives of the Study are to evaluate the effect of three
different doses of Orenetide and placebo, on (1) sexual desire, as measured by
the Female Sexual Function Index (FSFI) desire domain; and, (2) the degree to
which a participant is bothered by low sexual desire, as measured by the
Female Sexual Distress Scale. The change in those clinically relevant and
validated endpoints will be assessed between a four-week baseline period and
after four weeks of daily dosing. All study participants are female and have a
diagnosis of acquired, generalised HSDD. Orenetide is a synthetic peptide
administered through a nasal spray and has been supplied for this study by
well-established peptide manufacturers in Switzerland and the UK.

 

More information about the Phase II study can be found through clicking on the
following link: ACTRN12620001356954
(http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380376&isReview=true)

Data generated from previous clinical trials led to Marketing Authorization
being granted to Ovoca's subsidiary Ivix Ltd. by the Russian Ministry of
Health of Orenetide (under trade name of "Desirix") for treatment of HSDD in
Russia earlier in February 2022. The current Phase II Study will provide data
in a Western population fully compliant with the standards of the
International Conference on Harmonisation that, if successful in validating
the results of the Russian studies and with completion of a preclinical
programme, will ultimately support further clinical development in the US, EU,
and internationally.

 

Dr. Daniil Nemenov, SVP for Clinical Development and Operations of Ovoca Bio
plc, said: "We are pleased to announce the completion of the recruitment of
participants in this important study. Despite the challenges encountered
during this recruitment journey, including significant COVID-related
restriction in Australia and New Zealand, we saw significant enthusiasm and
willingness to participate in our study among the target patient population -
women with distressing problems with their libido. This once again confirms
that we are working in a field of significant unmet medical need, where
Orenetide may be a sought-after product."

 

Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said: "We are
delighted that all participants have been enrolled in this Phase II study as
we continue towards our goal of establishing the value of Orenetide as a
potential treatment for HSDD around the world. We hope that this clinical
study will pave the way for the development of Orenetide in wider
international markets, including the US and EU. We look forward to providing
further updates in due course."

 

End

 

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel +353 1 661 9819

info@ovocabio.com (mailto:info@ovocabio.com)

 

Davy (Nominated Adviser, Euronext Growth Listing Sponsor and Broker)

Ivan Murphy / Daragh O'Reilly

Tel: +353 1 679 6363

 

 

About Ovoca Bio

Ovoca Bio is a European-based biopharmaceutical company with a focus on
women's health. The Company is currently developing a novel treatment for
women with hypoactive sexual desire disorder (HSDD), a condition characterized
by a distressing lack or loss of sexual desire affecting an estimated ~4
million premenopausal women in the US alone.

 

The Company's lead product, Orenetide (BP-101), a novel synthetic peptide
administered through a nasal spray, is clinically validated, with Phase II and
Phase III studies conducted in Russia demonstrating statistically significant
improvement in a number of key efficacy outcomes, including an increase in
female sexual desire and reduction of symptoms of distress associated with
HSDD.

 

Ovoca Bio has been granted marketing approval in the Russian Federation and is
seeking to develop the drug for major global markets - in particular the
United States and Europe.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCZVLFLLDLXBBX